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August 9, 2023: MLN MM13278: ICD-10 & Other Coding Revisions to National Coverage Determinations: January 2024 Update
Relevant National Coverage Determinations (NCDs) include NCD 50.3 (Cochlear Implants), NCD 90.2. (Next Generation Sequencing (NGS), and NCD 210.1 (Prostate Screening Tests). Make sure your billing staff are aware of newly available codes, recent coding changes, and how to find NCD coding information. https://www.cms.gov/files/document/mm13278-icd-10-other-coding-revisions-national-coverage-determinations-january-2024-update.pdf
August 9, 2023: MLN MM13288: National Coverage Determination 30.3.3 – Acupuncture for Chronic Low Back Pain
Make sure your billing staff knows about updated frequency edits for acupuncture for chronic low back pain (cLBP) and relevant codes for acupuncture and dry needling services starting January 1, 2024. Reminder, CMS won’t cover more than 20 acupuncture treatments annually. https://www.cms.gov/files/document/mm13288-national-coverage-determination-3033-acupuncture-chronic-low-back-pain.pdf
Compliance Education Updates
August 2023: MLN Booklet Federally Qualified Health Center Revised
There have been several updates made to this MLN booklet. For example, CMS clarified the definition of telehealth and added consent for information for care management and virtual communications services. https://www.cms.gov/files/document/mln006397-federally-qualified-health-center.pdf
July 27, 2023: MLN Connects Notification: CMS Updated the Discarded Drugs and Biologicals – JW Modifier and JZ Modifier Policy FAQs
In the July 27, 2023 edition of MLN Connects, CMS notes that they have updated the Discarded Drugs and Biologicals – JW Modifier and JZ Modifier Policy FAQs to clarify the applicability of the reporting requirements to various outpatient settings and certain not otherwise classified billing codes. They also clarify how to use the JW and JZ modifiers when you prepare the dose with more than 1 single-dose container.
Finally, they remind providers that they use the JW and JZ Modifiers to collect information on discarded drug amounts from drugs that are packaged in single-dose containers that are separately payable under Part B.
Starting July 1, 2023, report the JZ modifier when there are no discarded amounts and report the JQ modifier when there are discarded amounts. https://www.cms.gov/outreach-and-education/outreach/ffsprovpartprog/provider-partnership-email-archive/1368246344/2023-07-27-mlnc
August 16, 2023: CMS Fact Sheet: Anniversary of the Inflation Reduction Act: Update on CMS ImplementationIn this Fact Sheet, CMS details Milestones that they have met for implementing the provisions in this Act. You will also find links to public education resources that CMS has produced to help people with Medicare and those who assist them understand the changes under the new drug law (i.e., Frequently Asked Questions: Medicare Part B & D Insulin Benefit). https://www.cms.gov/newsroom/fact-sheets/anniversary-inflation-reduction-act-update-cms-implementation
Did You Know?
It has been almost two years since the October 2021 release of the CMS Change Request (CR) 12471 (https://www.cms.gov/files/document/R11059CP.pdf). There were two stated purposes for this CR noted in the Summary of Changes:
- Implement system changes needed to update the Shared System Maintainer (SSM) interface with the Java MCE to accept new MCE Edit 20-Unspecific Code Edit, and
- Provide a mechanism to systematically bypass the new edit when a specific billing note is present in the claim remarks field to indicate the primary reason why laterality could not be determined.
Why this Matters?
In ICD-10-CM there are unspecified codes for when documentation in the record does not provide detail needed to report a more specific code. “However, in the inpatient setting, there should generally be very limited and rare circumstances for which the laterality (right, left, bilateral) of a condition is unable to be documented and reported.”
Effective for claims with dates of service on or after April 1, 2022, new Code Edit 20- will be triggered when an unspecified diagnosis code currently designated as either a Complication or Comorbidity (CC) or Major Complication or Comorbidity (MCC), that includes other codes in that code subcategory that further specify the anatomic site, is entered.
You will find the initial complete list of 3,432 ICD-10-CM unspecified codes subject to this edit in table 6P.3a associated with the FY 2022 IPPS/LTCH Final Rule (https://www.cms.gov/medicare/acute-inpatient-pps/fy-2022-ipps-final-rule-home-page).
This edit is meant to signal providers that there is a more specific laterality code available to report. It will be the provider’s responsibility to determine if documentation in the medical record supports a more specific code. “If, upon review, additional information to identify the laterality from the available medical record documentation by any other clinical provider is unable to be obtained or there is documentation in the record that the physician is clinically unable to determine the laterality because of the nature of the disease/condition, then the provider must enter that information in the remarks section.”
Mechanism to Bypass new MCE Edit 20-
The provider may enter a remark:
- Either “UNABLE TO DET LAT 1” to indicate that they are unable to obtain additional information to specify laterality, or
- “UNABLE TO DET LAT 2” to indicate the physician is clinically unable to determine laterality.
Entering this language will enable your MAC to systematically bypass the edit and process your claim.
However, “if there is no language entered into the remarks section as to the availability of additional information to specific laterality and the provider submits the claim for processing, the claim would be returned to the provider.”
New Unspecified Codes Subject to MCE Edit 20-
In the FY 2024 IPPS Final Rule, CMS finalized the addition of six new diagnosis codes that are designated as a CC to the Unspecified code edit code list and four diagnosis codes that were inadvertently omitted from the Unspecified code edit list effective with discharges on or after April 1, 2022.
New FY 2024 Unspecified ICD-10-CM Diagnosis Codes
- M80.0B9A: Age-related osteoporosis with current pathological fracture, unspecified pelvis, initial encounter for fracture
- M80.0B9K: Age-related osteoporosis with current pathological fracture, unspecified pelvis, subsequent encounter for fracture with nonunion
- M80.0B9P: Age-related osteoporosis with current pathological fracture, unspecified pelvis, subsequent encounter for fracture with malunion
- M80.8B9A: Other osteoporosis with current pathological fracture, unspecified pelvis, initial encounter for fracture
- M80.8B9K: Other osteoporosis with current pathological fracture, unspecified pelvis, subsequent encounter for fracture with nonunion
- M80.8B9P: Other osteoporosis with current pathological fracture, unspecified pelvis, subsequent encounter for fracture with malunion
- L89.103: Pressure ulcer of unspecified part of back, stage 3
- L89.104: Pressure ulcer of unspecified part of back, stage 4
- L89.93: Pressure ulcer of unspecified site, stage 3
- L89.94: Pressure ulcer of unspecified site, stage 4
What Can You Do?Share this information with key stakeholders at your facility (i.e., Billing, Coding, Clinical Documentation Integrity Specialists) including background information found in CR 12471 and related MLN Matters article MM12471 (https://www.cms.gov/files/document/mm12471-april-2022-update-java-medicare-code-editor-mce.pdf).
CMS finalized several changes to the Major Diagnostic Category (MDC) 05: Diseases and Disorders of the Circulatory System for FY 2024. This article focuses on the finalized changes in MDC 5. You can read about finalized changes in other MDCs in a related article in this week’s newsletter.
A request was made for CMS to review the MS-DRG assignment of cases involving open concomitant surgical ablation procedures, recommending that open concomitant surgical ablation procedures for atrial fibrillation (AF) be reassigned from MS-DRGs 219, 220, and 221 (Cardiac Valve and Other Major Cardiothoracic Procedures without Cardiac Catheterization with MCC, with CC, and without CC/MCC, respectively) to MS-DRGs 216, 217, and 218 or create new MS-DRGs for all open mitral or aortic valve repair or replacement procedures with concomitant surgical ablation of AF.
Analysis showed that these cases require greater resources, have higher average costs and generally longer lengths of stay compared to all other cases in their assigned MS-DRG. Based on this analysis, CMS finalized their proposal to create a new base MS-DRG 212 (Concomitant Aortic and Mitral Valve Procedures) for cases reporting an aortic valve repair or replacement procedure, a mitral valve repair or replacement procedure, and another concomitant procedure in MDC 05.
In response to comments that the logic intent for assignment to new MS-DRG 212 was not clear. CMS clarified that cases reporting: (1) aortic valve repair or replacement procedure; (2) a mitral valve repair or replacement procedure; and (3) at least one other concomitant procedure, as defined in the GROUPER logic, would be assigned to new MS-DRG 212.
External Heart Assist Device
Currently, the three ICD-10-PCS procedure codes describing the insertion of a short-term heart assist device are recognized as extensive O.R. procedures assigned to MS-DRG 215 (Other Heart Assist System Implant) in MDC-05. Procedure code 02HA0RZ (Insertion of short-term external heart assist system into heart, open approach) describes an open approach. The other two procedure codes describe a percutaneous approach.
CMS has finalized their proposal to reassign the open approach procedure code when reported as a standalone procedure from MS-DRG 215 in MDC-05 to Pre-MDC MS-DRGs 001 and 002. Effective October 1, 2023, procedure code 02HA0RZ code will no longer need to be reported as a part of a procedure code combination or procedure code “cluster” to satisfy the logic assignment for MS-DRGs 001 and 002.
Ultrasound Accelerated Thrombolysis (UAST) for Deep Vein Thrombosis
A request was made to reassign cases reporting USAT of peripheral vascular structures procedures with the administration of thrombolytic(s) for deep venous thrombosis from MS-DRGs 252, 253, and 254 (Other Vascular Procedures with MCC, with CC, and without CC/MCC, respectively) to MS-DRGs 270, 271, and 272 (Other Major Cardiovascular Procedures with MCC, with CC, and without CC/MCC, respectively).
CMS found this subset of cases did not clinically align with patients undergoing surgery for acute myocardial infarction. However, the identified difference in resource consumption did warrant creating a new MS-DRG to reflect more appropriate payment for USAT and standard catheter-directed thrombolysis (CDT) procedures of peripheral vascular structures. CMS finalized their proposal to create new MS-DRGs 278 and 279 (Ultrasound Accelerated and Other Thrombolysis of Peripheral Vascular Structures with MCC and without MCC, respectively).
Coronary Intravascular Lithotripsy
A request was made to review MS-DRG assignment of cases describing percutaneous intravascular lithotripsy (IVL) involving the insertion of drug eluting and non-drug eluting stents. According to the requestor, cases involving IVL are more complex as this is a therapy deployed exclusively in several calcified coronary lesions that are associated with longer procedure times and increased resources.
CMS analysis showed that cases reporting percutaneous coronary IVL, with or without a stent had higher average costs and lengths of stay. CMS finalized their proposal to create MS-DRGs 323 and 324 (Coronary Intravascular Lithotripsy with Intraluminal Device with MCC and without MCC, respectively), and MS-DRG 325 (Coronary Intravascular Lithotripsy without Intraluminal Device).
Eliminating Distinction Between Bare-Metal and Drug-Eluting Stent (DES)
CMS noted in the proposed rule that it appears to no longer be necessary to subdivide the MS-DRGs for percutaneous cardiovascular procedures based on the type of coronary intraluminal device inserted. After consideration of public comments, CMS finalized their proposals to
- Delete MS-DRGs 246, 247, 248, and 249,
- Create new MS-DRG 321 (Percutaneous Cardiovascular Procedures with Intraluminal Device with MCC or 4+ Arteries/Intraluminal Devices) and MS-DRG 322 (Percutaneous Cardiovascular Procedures with Intraluminal Device without MCC),
- Reassign procedure codes from current MS-DRGs 246, 247, 248, and 249 to the new MS-DRGs 321 and 322, and
- Revise the titles for MS-DRGs 250 and 251 from “Percutaneous Cardiovascular without Coronary Artery Stent with MCC, and without MCC, respectively” to “Percutaneous Cardiovascular Procedures without Intraluminal Device with MCC, and without MCC, respectively” to better reflect the ICD-10-PCS terminology of “intraluminal devices” versus “stents” as used in the procedure code titles within the classification.
Cardiac Defibrillators and Shock
During a review of cardiogenic shock, CMS noted data analysis shows the average costs and length of stay are generally similar for cardiac defibrillator cases without regard to the presence of AMI, Heart Failure (HF), or shock. CMS finalized their proposals to:
- Delete MS-DRGs 222, 223, 224, 225, 226, and 227,
- Create three new MS-DRGs: MS-DRG 275 (Cardiac Defibrillator Implant with Cardiac Catheterization and MCC, and MS-DRGs 276 and 277 (Cardiac Defibrillator Implant with MCC, and without MCC, respectively), and
- Specific to MS-DRG 275, designate procedure codes describing cardiac catheterization as non-O.R. procedures affecting the MS-DRG.
The finalized changes go into effect October 1, 2023.
Resource: FY 2024 IPPS Final Rule (CMS-1785-F) webpage at https://www.cms.gov/medicare/acute-inpatient-pps/fy-2024-ipps-final-rule-home-page
The FY 2024 IPPS Final Rule (CMS-1785-F) was issued August 1, 2023. This article focuses on final changes to Medicare Severity Diagnosis-Related Group (MS-DRG) classifications in Major Diagnostic Categories (MDCs) 02, 04, and 06 (Diseases and Disorders of the Eye, Respiratory System, and Digestive System, respectively).
MDC 02: Diseases and Disorders of the Eye: Retinal Artery Occlusion
A request was made to review the MS-DRG assignment of cases involving central retinal artery occlusion (CRAO). The assertion was that CRAO is a form of acute ischemic stroke which occurs when a vessel supplying blood to the brain is obstructed and there is growing recognition of this diagnosis as a vascular neurological problem. New evidence outlines treatment of patients with CRAO with acute stroke protocols, specifically with intravenous thrombolysis or hyperbaric oxygen therapy, to improve outcomes. Based on this request, data analysis and examining clinical considerations, CMS finalized their proposals to:
- Reassign ICD-10-CM diagnosis codes H34.10, H34.11, H34.12, H34.13, H34.231, H34.232, H34.233, and H34.239 from MDC 02 MS-DRG 123 to MS-DRGs 124 and 125,
- Add procedure codes describing the administration of a thrombolytic agent listed in this section to MS-DRG 124,
- As part of the logic for MS-DRG 124, designate the administration of thrombolytic agent codes as non-O.R. procedures affecting the MS-DRG, and
- Change the titles of MS-DRGs 124 and 125 from “Other Disorders of the Eye, with and without MCC, respectively,” to “Other Disorders of the Eye with MCC or Thrombolytic Agent, with without MCC, respectively” to better reflect the assigned procedures.
MDC 04: Diseases and Disorders of the Respiratory System: Ultrasound Accelerated Thrombolysis for Pulmonary Embolism
A request was made to reassign cases reporting ultrasound accelerated thrombolysis (USAT) with administration of thrombolytic(s) for the treatment of pulmonary embolism (PE) from MS-DRGs 166, 167, and 168 (Other Respiratory O.R. Procedures with MCC, with CC, and without CC/MCC, respectively) to MS-DRGs 163, 164, and 165 (Major Chest Procedures with MCC, with CC, and without CC/MCC, respectively).
Clinical and data analyses support creating a new base MS-DRG for cases reporting a principal diagnosis of PE and USAT or standard catheter directed thrombolysis (CDT) procedures with or without thrombolytics. CMS finalized their proposal to create a new MS-DRG 173 (Ultrasound Accelerated and Other Thrombolysis with Principal Diagnosis Pulmonary Embolism).
MDC 04: Respiratory Infections and Inflammations Logic
There are two logic lists for case assignment to MS-DRGs 177, 178, and 179 (Respiratory Infections and Inflammations with MCC, with CC, without CC/MCC, respectively). All diagnosis codes in the first logic list are designated as MCCs.
Currently, if the principal diagnosis is from the second logic list and any of the diagnoses from the first logic list are also on the claim, the case would be assigned to MS-DRG 177. This is inconsistent with how other similar logic lists function in the ICD-10 grouper software. Therefore, CMS proposed to correct the logic for cases assigned to MS-DRG 177 by excluding the 15 diagnosis codes in the first logic list from acting as an MCC when reported as a secondary diagnosis when the principal diagnosis is from the second logic list.
CMS finalized their proposal with the modification of excluding 11 diagnosis codes in the first logic list from acting as an MCC when any one of the listed codes is reported as a secondary diagnosis with a diagnosis code in the second logic list.
The 11 diagnosis codes includes A48.1 (Legionnaire’s disease), J15.0 (Pneumonia due to Klebsiella pneumoniae), J15.1 (Pneumonia due to Pseudomonas), J15.20 (Pneumonia due staphylococcus, unspecified), J15.211 (Pneumonia due to Methicillin susceptible Staphylococcus aureus), J15.212 (Pneumonia due Methicillin resistant Staphylococcus aureus), J15.29 (Pneumonia due to other staphylococcus), J15.5 (Pneumonia due to Escherichia coli), J15.61 (Pneumonia due to Acinetobacter baumannii), J15.69 (Pneumonia due to other Gram-negative bacteria), and J15.8 (Pneumonia due to other specified bacteria).
The five influenza codes in the first logic list (J10.00, J10.01, J10.08, J11.00, or J11. 08) will continue to be allowed to act as an MCC with a principal diagnosis from the second logic list in specific clinical scenarios.
MDC 06: Diseases and Disorders of the Digestive System: Appendicitis
ICD-10-CM diagnosis codes K35.20 (Acute appendicitis with generalized peritonitis, without abscess) and K35.21 (Acute appendicitis with generalized peritonitis, with abscess) will no longer be effective October 1, 2023. At that time, six new diagnosis codes describing acute appendicitis with generalized peritonitis, with and without perforation or abscess will become effective. The new codes are assigned to MS-DRGs 371, 372, and 373 (Major Gastrointestinal Disorders and Peritoneal Infections with MCC, with CC, and without MCC/CC, respectively).
CMS notes that clinically both localized and generalized peritonitis in association with an appendectomy require the same level of patient care and believe the distinction between “complicated” versus “uncomplicated” is no longer meaningful regarding resource consumption. After consideration of comments received, CMS finalized their proposals to:
- Delete MS-DRGs 338, 339, 340, 341, 342, and 343,
- To create new MS-DRGs 397, 398, and 399 (Appendix Procedures with MCC, with CC, and without CC/MCC, respectively), and
- To no longer require a diagnosis in the definition of the logic for case assignment for the new MS-DRGs.
The finalized changes go into effect October 1, 2023.
CMS issued a display copy of the FY 2024 IPPS Final Rule on Monday, August 1, 2023. This article contains a high-level look at the final operating payment rate changes, Rural Emergency Hospitals change, social determinants of health codes severity designation changes, when the New COVID-19 Treatment Add-On Payments are set to end, and updates to the Affordable Care Act Quality Programs.
Proposed Payment Rate Changes
The proposed increase in operating payment rates for general acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting (IQR) Program and meaningful electronic health record (EHR) use was 2.8%. This finalized increase is 3.1%.
The increase in operating and capital payment rates will generally increase hospital payments in FY 2024 by $2.2 billion.
Rural Emergency Hospitals (REHs) and Graduate Medical Education (GME)
REH’s became a new provider type effective January 1, 2023. You can read more about them in a related MLN Fact Sheet. CMS finalized their proposal to allow REH’s serve as training sites for Medicare GME payment purposes to “help support graduate medical training in rural areas.”
Severity Level Designation Change for Z Codes Describing Homelessness
The U.S. Department of Health and Human Services (HHS) defines Social Determinants of Health (SDOH) as "the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks." Effective February 18, 2018, the AHA Coding Clinic published advice allowing the reporting of SDOH codes Z55-Z65, based on information documented by all clinicians involved in the care of the patient.
For FY 2024, CMS finalized their proposal to change the severity level designation for diagnosis codes Z59.00 (Homelessness, unspecified), Z59.01 (Sheltered homelessness), and Z59.02 (Unsheltered homelessness) from NonCC to CC for FY 2024.
COVID-19 Treatment Add-On Payment (NCTAP) to End September 30, 2023
In response to the Public Health Emergency (PHE), CMS established NCTAP for eligible discharges during the PHE. In the FY 2022 final rule, CMS finalized the extension of NCTAP through the end of the FY in which the PHE ends. With the PHE ending on May 11, 2023, discharges involving eligible products would continue to be eligible for the NCTAP through September 30, 2023 (that is, through the end of FY 2023).”
Affordable Care Act Quality Programs
Hospital Readmission Reduction Program (HRRP)
CMS did not propose or finalize any changes to this value-based purchasing program that reduces payments to hospitals with excess readmissions.
Hospital-Acquired Condition (HAC) Reduction Program
This program creates an incentive for hospitals to reduce the incidence of hospital-acquired conditions by reducing payment by 1% for applicable hospitals ranking in the worst-performing quartile on select measures. For FY 2023, due to the ongoing COVID-19 PHE, no hospital was subject to the 1-percent payment reduction. You can read more about this program in a related FY 2023 CMS Fact Sheet.
For FY 2024, CMS finalized the proposal to establish a validation reconsideration process for hospitals who fail data validation beginning with the FY 2025 program year, affecting calendar year 2022 discharges. They also finalized modification of the validation targeting criteria to include hospitals granted extraordinary circumstances exceptions (ECEs) beginning with the FY 2027 program year, affecting calendar year 2024 discharges.
Hospital Value-Based Purchasing (VBP) Program
This is a budget-neutral program funded by reducing hospitals’ base operating DRG payments each fiscal year by 2% and redistributing the entire amount back to the hospitals as value-based incentive payments. Like the HAC Reduction Program, CMS finalized hospitals’ keeping the 2% payment due to the ongoing COVID-19 PHE. For FY 2024, CMS finalized several changes to this program for FY 2024, for example, CMS:
- Adopted the Severe Sepsis and Septic Shock: Management Bundle measure in the Safety Domain beginning with the FY 2026 program year.
- Adopted a modified version of the Medicare Spending Per Beneficiary (MSPB) Hospital measure beginning with the FY 2028 program year, and
- Adopted a modified version of the Hospital-level Risk-Standardized Rate (RSCR) Following Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee Arthroplasty (TKA) measure beginning with the FY 2030 program year.
August 1, 2023 CMS Fact Sheet: FY 2024 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule – CMS-1785-F and CMS-1788-F Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/fy-2024-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospital-prospective-0CMS FY 2024 Final Rule Home Page: https://www.cms.gov/medicare/acute-inpatient-pps/fy-2024-ipps-final-rule-home-page
What code do we assign when the Place of Occurrence or the Activity the patient was doing when an injury occurred is not documented?
Per the 2023 Coding Guidelines, Y92.9, Place of Occurrence or Not Applicable and Y93.9, Unspecified Activity, are not to be assigned when the information is not documented.
Coding Guidelines for Place of Occurrence, 2023
Coding Guidelines for Activity Code, 2023
Did You Know?
August is National Immunization Awareness Month (NIAM). According to the CDC, NIAM “is an annual observance held in August to highlight the importance of routine vaccination for people of all ages.”
Why It Matters?
Immunity from childhood vaccines can wear off over time. Keeping your vaccinations up to date throughout life helps you combat vaccine preventable diseases. The CDC advises that all adults need a COVID-19 vaccine, Influenza (flu) vaccine every year, and Tetanus and diphtheria (Td) or Tetanus, diphtheria, and pertussis (Tdap) vaccine every ten years.
Additional Key Vaccines
Shingles Vaccine (Shingrix)
The two-dose series of shots to protect against shingles. The CDC cites that “in adults 50 years and older who have healthy immune systems, Shingrix is more than 90% effective at preventing shingles” and postherpetic neuralgia (PHN)< the most common complication from shingles.”
In 2022, the percent of adults aged eighteen and over who had ever received a pneumococcal vaccination was only 23.9%. Older adults are at greatest risk of serious illness and death from pneumococcal disease. In the United States, there are two kinds of vaccines to help prevent pneumococcal disease, Pneumococcal conjugate vaccines (PCV 13, PCV15, and PCV20), and Pneumococcal polysaccharide vaccine (PPSV23).
PCV13: Prevnar 13® (pneumococcal conjugate vaccine or PCV13) is a registered trademark by Wyeth LLC and marketed by Pfizer Inc. This vaccine provides protection against infections caused by six more serotypes than PCV7. This vaccine is part of the routine childhood immunization schedule. Additionally, in 2011, it was licensed by the FDA for use in adults 50 years or older.
The CDC recommends PCV13 for all children younger than 2 years old, and people 2 years or older with certain medical conditions.
The CDC advises adults 65 years and older to discuss the need for this vaccine with their health care provider.
PCV 15: Vaxneuvance™ (Pneumococcal 15-valent Conjugate Vaccine)
On July 16, 2021, Merck announced the FDA approval of Vaxneuvance™, a new vaccine for the prevention of invasive pneumococcal disease in adults 18 years and older caused by 15 serotypes.
PCV20: Prevnar 20™ (Pneumococcal 20-valent Conjugate Vaccine)
On June 8, 2021, Pfizer announced the FDA approval of the Prevnar 20™ vaccine for adults 18 years or older and noted that it is “the first approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S.”
PPSV23: Pneumovax23® (pneumococcal polysaccharide vaccine or PPSV23) is a Merck product. This vaccine was approved by the FDA in 1983 and helps protect against twenty-three types of pneumococcal bacteria.
The CDC recommends this vaccine for all adults 65 years or older, people 2 through 64 years old with certain medical conditions (i.e., diabetes, heart disease or COPD), and adults 19 through 64 years old who smoke cigarettes.
Respiratory Syncytial Virus (RSV) Vaccine
On May 3, 2023, the FDA announced they had approved Arexvy, the first RSV vaccine approved in the United States for the prevention of lower respiratory tract disease caused by RSV in people 60 years of age and older.
On June 29, 2023, the CDC endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendations for use of the RSV vaccine in people ages 60 years or older. They noted that “Adults at the highest risk for severe RSV illness include older adults, adults with chronic heart or lung disease, adults with weakened immune systems, and adults living in nursing homes or long-term care facilities. CDC estimated that every year, RSV causes approximately 60,000-160,000 hospitalizations and 6,000-10,000 deaths among older adults.”
What Can I Do?
As a Healthcare Provider
Work with your patients to identify what vaccinations they have and have not received and utilize available resources on the CDC website for healthcare providers related to immunization schedules.
As a Healthcare Consumer
Keep your vaccination records up to date, use the CDC’s Adult Vaccine Assessment Tool to determine which vaccines are recommended for you, and share all this information with your healthcare provider so you make an informed decision on what immunizations you may need.
- National Immunization Awareness Month: https://www.cdc.gov/vaccines/events/niam/
- Vaccine Information for Adults: https://www.cdc.gov/vaccines/adults/index.html
- Shingles Vaccination: https://www.cdc.gov/vaccines/vpd/shingles/public/shingrix/index.html
Merck July 16, 2021 Announcement: https://www.merck.com/news/merck-announces-u-s-fda-approval-of-vaxneuvance-pneumococcal-15-valent-conjugate-vaccine-for-the-prevention-of-invasive-pneumococcal-disease-in-adults-18-years-and-older-caused-by-15-serot/
Pfizer June 8, 2021 Announcement: https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-prevnar-20tm-pfizers-pneumococcal-20-valent
FDA May 3, 2023 RSV Vaccine Announcement: https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine?utm_medium=email&utm_source=govdelivery
June 29, 2023 CDC Announcement Recommending RSV Vaccine for Older Adults: https://www.cdc.gov/media/releases/2023/s0629-rsv.html
CMS published the CY 2024 OPPS/ASC Proposed Rule on July 13, 2023. By now, many news outlets have authored articles about this proposed rule. This article highlights topics that historically our clients have reached out to us to learn about.
Medicare Inpatient Only (IPO) Procedure List
Although CMS received several requests recommending services for removal from the IPO list, CMS did not find sufficient evidence that met the criteria and did not propose to remove any service from the IPO list for CY 2024.
CMS has proposed to add nine services with newly created codes by the AMA CPT Editorial Panel which will be in effect January 1, 2024 to the list and to reassign CPT code 0646T (Transcatheter tricuspid valve implantation (ttvi)/replacement with prosthetic valve, percutaneous approach, including right heart catheterization, temporary pacemaker insertion, and selective right ventricular or right atrial angiography, when performed) from status indicator “E1” to status indicator “C.” The proposed changes are available in Table 47 of the proposed rule.
OPPS Payment Methodology for 340B OPPS Payment Methodology for Purchased Drugs and Biologicals
On July 7, 2023, CMS published a proposed rule, referred to as “remedy proposed rule” to address reduced payment amounts to 340B hospitals for CYs 2018 through 2022 and to comply with the statutory requirement to maintain budget neutrality. The “remedy proposed rule” proposes changes to the calculation of the OPPS conversion factor beginning in CY 2025.
In the “remedy proposed rule,” CMS proposes to make one time lump-sum payments to each of the approximately 1,600 340B covered entity hospitals. Addendum AAA to the proposed rule lists the proposed lump-sum payment for each eligible hospital.
For CY 2024, CMS proposes to continue to pay the statutory default rate, which is generally ASP plus 6 percent.
340B Modifiers “JG” and “TB”
The Inflation Reduction Act of 2022 expanded the provider types that must report one of these modifiers no later than January 1, 2024 to now include critical access hospitals, Maryland All-Payer or Total Cost of Care Model Hospitals, and Non-excepted off-campus provider-based departments (PBD).
In the CY 2023 OPPS/ASC final rule, CMS maintained the requirements that 340B hospitals report one of two modifiers, “JG” – Drug or biological acquired with 340B drug pricing program discount, reported for informational purposes, or “TB” – Drug or biological acquired with 340B drug pricing program discount, reported for informational purposes for select entities.
In the CY 2024 OPPS/ASC proposed rule, CMS notes they “now believe utilizing a single modifier will allow for greater simplicity, especially because both modifiers are used for the same purpose: to identify separately payable drugs and biologicals acquired under the 340B program.”
CMS is proposing that all 340B covered entity hospitals would report the “TB” modifier effective January 1, 2025, even if the hospital previously reported the “JG” modifier. The “JG” modifier will remain effective through December 31, 2024. Beginning January 1, 2025, the “JG” modifier would be deleted.
CMS notes hospitals currently using the “JG” modifier could choose to continue to use it in CY 2024 or choose to transition to the “TB” modifier during that year.
Payment for Intensive Cardiac Rehabilitation Services (ICR) Provided by an Off-Campus Non-Excepted Provider Based Department (PBD) of a Hospital
CMS identified a disparity in payment for ICR services between services provided in a physician’s office and the same services provided by an off-campus, non-excepted PBD and notes that this “creates a significant barrier to beneficiary access to an already underutilized service.”
To eliminate this unintended outcome CMS is proposing the following:
“Pay for ICR services provided by an off-campus, non-excepted provider-based department of a hospital at 100 percent of the OPPS rate for CR services (which is also 100 percent of the PFS rate) rather than at 40 percent of the OPPS rate,” and
“Effective January 1, 2024, we propose to exclude ICR from the 40 percent Relativity Adjuster policy at the code level by modifying the claims processing of HCPCS codes G0422 (Intensive cardiac rehabilitation; with or without continuous ECG monitoring with exercise, per session) and G0423 (Intensive cardiac rehabilitation; with or without continuous ECG monitoring without exercise, per session) so that 100 percent of the OPPS rate for CR is paid irrespective of the presence of the “PN’’ modifier (signifying a service provided in a non-excepted off-campus provider-based department of a hospital) on the claim.”
Proposed Additions to the ASC Covered Procedures List (CPL) for CY 2024
CMS is proposing to update the ASC CPL by adding 26 dental surgical procedures. They note that they “expect to continue to gradually expand the ASC CPL, as medical practice and technology continue to evolve and advance in future years,” and encourage stakeholders to submit procedure recommendations to be added to the ASC CPL.
Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging
Although this falls under the purview of the CY 2024 Physician Fee Schedule Proposed Rule, I often receive questions from clients regarding when CMS plans to fully implement this program.
In the proposed rule, CMS notes that they “exhausted all reasonable options for fully operationalizing the AUC program,” and “propose to pause implementation of the AUC program for reevaluation and rescind the current AUC program regulations from §414.94.” They “expect this to be a hard pause to facilitate thorough program reevaluation and, as such…are not proposing a time frame within which implementation efforts may recommence.”
The comment period for the CY 2024 Hospital OPPS/ASC and Physician Fee Schedule Proposed Rules ends on September 11, 2023. I encourage you to take the time to review the proposed rules and submit comments.
Hospital Outpatient Prospective Payment-Notice of Proposed Rulemaking with Comment Period CY
Hospital Outpatient Prospective Payment Remedy for the 340B-Acquired Drug Payment Policy-Notice of Proposed Rulemaking with Comment Period: https://www.cms.gov/medicare/medicare-fee-service-payment/hospitaloutpatientpps/hospital-outpatient-regulations-and/cms-1793-p
MLN Fact Sheet: Medicare Part B Inflation Rebate Guidance: Use of the 340B Modifier (MLN4800856 March 2023): https://www.cms.gov/files/document/mln4800856-medicare-part-b-inflation-rebate-guidance-use-340b-modifier.pdf
CY 2024 Physician Fee Schedule Proposed Rule: https://www.cms.gov/medicare/medicare-fee-for-service-payment/physicianfeesched
Medicare Transmittals & MLN Articles
June 30, 2023: MLN MM13269: ICD-10 & Other Revisions to Laboratory National Coverage Determinations: October 2023 Update
CMS advises that you make sure your billing staff is aware of newly available codes, recent coding changes, and how to find NCD coding information. https://www.cms.gov/files/document/mm13269-icd-10-other-coding-revisions-laboratory-ncds-october-2023-update.pdf
July 5, 2023: MLN Matters MM13216: Ambulatory Surgical Center Payment System: July 2023 Update - Revised
Now in it’s fourth iteration, CMS has revised this MLN article to change the number of separately payable drugs in Section 5.a to 18 to agree with the change for HCPCS J9322 in Table 3 of Change Request (CR) 13216. Substantive changes are in dark red on page 3. https://www.cms.gov/files/document/mm13216-ambulatory-surgical-center-payment-system-july-2023-update.pdf
July 11, 2023: MLN SE19007: Activation of Validation Edits for Providers with Multiple Service Locations – Revised
Now in its fifth iteration, CMS has revised this special edition MLN article to add information on Round 5 testing and national implementation of edits. Substantive changes are in dark red on pages 1 and 4. Note that these are not new requirements, but CMS did announce a delay of activation of these edits on March 24, 2022 until further notice. On August 1, 2023, CMS will start deploying editing into full procedure and have told the MACs to develop implementation plans to permanently turn on the Reason Codes and set them up to RTP claims that don’t match exactly. https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnmattersarticles/downloads/se19007.pdf
July 17, 2023: Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease Proposed Decision Memo
CMS is proposing to remove National Coverage Determination (NCD) 220.6.20, ending coverage with evidence development (CED) from positron emission tomography (PET) beta amyloid imaging and permitting Medicare coverage determinations for PET beta amyloid imaging be made by the Medicare Administrative Contractors (MACs). https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=308
July 20, 2023: HCPCS Modifier JZ Reminder
Palmetto GBA JJ Part B published a reminder that “the JZ HCPCS modifier is reports on a claim to attest that no amount of drug was discarded and eligible for payment. The modifier should only be used for claims that bill for single-dose container drugs. Effective July 1, 2023 providers are required to use the JZ modifier on applicable claims. https://www.palmettogba.com/palmetto/jjb.nsf/DID/1HF9LYKONE#ls
Compliance Education Updates
June 2023: Medicare’s Home Health Benefit Brochure Revised
CMS has revised their Medicare home health brochure. This brochure includes information about a beneficiary knowing their rights, where to get more information, what is covered, who can get covered home health care, what to pay, and how to protect yourself and Medicare from fraud. https://tinyurl.com/yc2ej3sv
June 2023: MLN Fact Sheet Telehealth Services Revised
CMS has recently updated this Fact Sheet and notes that they have made significant updates to explain recent policy changes. https://www.cms.gov/files/document/mln901705-telehealth-services.pdf
June 29, 2023 HHS Press Release: CDC Recommends Older and Immunocompromised Adults to Receive the RSV Vaccine
HHS Secretary Xavier Becerra issued the following statement in response to the CDC recommendation of the Respiratory Syncytial Virus (RSV) vaccine for seniors over 60: “For the first time in U.S. history, people 60 years and older can now receive a vaccine for protection against RSV virus…As we prepare for the fall vaccine campaign, we will follow the data and science to protect our nation’s most vulnerable adults, those living in nursing or long-term care facilities, and the immunocompromised.” https://tinyurl.com/yw9buepd
June 29, 2023: MLN Connects: New TCET Pathway
CMS published the following information in the June 29, 2023 edition of MLN Connects:
CMS is committed to fostering innovation while ensuring that people with Medicare have faster and more consistent access to emerging technologies that will improve health outcomes. As part of this commitment, CMS announced a proposed Transitional Coverage for Emerging Technologies pathway. This announcement includes a proposed procedural notice and several proposed guidance documents that propose a substantial transformation to our approach to coverage reviews and evidence development. Comment on the Federal Register notice by August 28. More Information:
June 29, 2023: MLN Connects: New Details of Plan to Cover New Alzheimer’s Drugs
CMS released new details about how people can get drugs that may slow the progression of Alzheimer’s disease covered by Medicare. Medicare will cover drugs with traditional FDA approval when a physician and clinical team participates in the collection of evidence about how these drugs work in the real world, also known as a registry. Clinicians will be able to submit this information through a nationwide, CMS-facilitated portal. Related CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/cms-announces-new-details-plan-cover-new-alzheimers-drugs
July 7, 2023: OPPS: Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022 Proposed Rule (CMS 1793-P)
In response to the Supreme Court’s decision in American Hospital Association v. Becerra (142 S. Ct. 1896 (2022), and the district court’s remand, CMS published a proposed rule to remedy the payment rates the Court held were invalid and noted that aspects of this proposed rule policy will affect nearly all hospitals paid under the OPPS. The proposed rule contains the calculations of the amounts owed to each of the approximately 1,600 affected 340B covered entity hospitals. The 60-day comment period will end on September 5, 2023.
July 12, 2023: Medicare Dental Services
CMS has created a Medical Dental Coverage webpage for health care providers. You will find links to information about what Medicare does and does not cover, what are inextricably linked dental services, if Medicare pays for multiple dental visits, who can provide and bill for dental services, how to submit a claim and additional resources. https://www.cms.gov/Medicare/Coverage/MedicareDentalCoverage
Beneficiary Notice of Noncoverage, Form CMS-R-131 Renewed
Reminder, the ABN, Form CMS-R-131, and form instructions have been approved by the Office of Management and Budget (OMB) for renewal. The renewed form has an expiration date of January 31, 2026, and became mandatory on June 30, 2023. Any ABN signed on or after June 30, 2023, with a prior expiration date will not be considered valid. https://www.cms.gov/medicare/medicare-general-information/bni/abn
July 20, 2023: The Joint Commission Eliminates Additional 200 Standards Across All Accreditation ProgramsThe Joint Commission announced in a press release that they are eliminating and consolidating more than 200 standards, effective August 27, 2023. “The second phase of this project includes a focus on The Joint Commission’s other accreditation programs in addition to the Hospital Accreditation Program (i.e., Ambulatory Health Care, Behavioral Health Care, and Laboratory). https://www.jointcommission.org/resources/news-and-multimedia/news/2023/07/the-joint-commission-eliminates-additional-200-standards-across-all-accreditation-programs/
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